Role Summary
The Director-level Project Statistician provides statistical leadership across Verve Gene-editing programs and Lilly Research Laboratory. They lead the assessment and adoption of new statistical technologies and methodologies, and guide the development of clinical plans, innovative protocol designs, and statistical analysis plans in collaboration with physicians and medical colleagues. They also provide consulting and statistical direction on priority clinical projects. Responsibilities
Statistical Trial Design and Analysis
Operate in collaboration with study personnel to provide input on study protocol, design studies and write protocols for the conduct of each study. Assist in or be accountable for selecting statistical methods for data analysis, authoring the corresponding sections of the protocol and the statistical analysis plan, and conducting the actual analysis once a reporting database is created. Collaborate with data sciences in the planning and implementation of data quality assurance plans. Maintain currency with respect to statistical methodology, maintain proficiency in applying new and varied methods, and to be competent in justifying methods selected. Influence team members regarding appropriate research methods Perform peer-review of work products from other statistical colleagues.
Communication of Results and Inferences
Collaborate with team members to write reports and communicate results. Assist with, or be responsible for, communicating study results via regulatory submissions, manuscripts, or oral presentations in group settings, as well as for communicating one-on-one with key customers and presenting at scientific meetings. Respond to regulatory queries and interact with regulators.
Therapeutic Area Knowledge
Understand disease states, competitive landscapes, and regulatory environment in order to enhance the level of customer focus and collaboration and be seen as a strong scientific contributor.
Regulatory Compliance
Perform work in full compliance with assigned curriculum(s) and will be responsible for following applicable Corporate, Medical, local, and departmental policies, procedures, processes, and training.
Statistical Leadership and Teamwork
Introduce and apply innovative methodology and tools to solve critical problems Merge scientific thinking and business knowledge to identify issues, evaluate options and implement solutions. Lead projects independently and work effectively across functions. Apply technical expertise to influence business decisions.
Qualifications
Required:
At least 7 years of proven experience in clinical research and development Preferred:
Significant experience with clinical trials, medical research, and/or real-world evidence Preferred:
Technical expertise and application with working knowledge of experimental design and statistical analysis Preferred:
An established track record of developing and maintaining an area of statistical or collaborative research Preferred:
Proficient in statistical programming languages/software such as SAS, R, Spotfire, WinBUG, etc Preferred:
Demonstrated problem solving ability and critical thinking Preferred:
Teamwork and leadership skills; ability to provide statistical leadership and technical expertise to influence business decisions Preferred:
Interpersonal communication skills for effective customer consultation and collaboration Preferred:
Creativity and innovation Preferred:
Business process expertise associated with critical activities (e.g. regulatory submissions) Education
Ph.D. in Statistics or Biostatistics
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The Director-level Project Statistician provides statistical leadership across Verve Gene-editing programs and Lilly Research Laboratory. They lead the assessment and adoption of new statistical technologies and methodologies, and guide the development of clinical plans, innovative protocol designs, and statistical analysis plans in collaboration with physicians and medical colleagues. They also provide consulting and statistical direction on priority clinical projects. Responsibilities
Statistical Trial Design and Analysis
Operate in collaboration with study personnel to provide input on study protocol, design studies and write protocols for the conduct of each study. Assist in or be accountable for selecting statistical methods for data analysis, authoring the corresponding sections of the protocol and the statistical analysis plan, and conducting the actual analysis once a reporting database is created. Collaborate with data sciences in the planning and implementation of data quality assurance plans. Maintain currency with respect to statistical methodology, maintain proficiency in applying new and varied methods, and to be competent in justifying methods selected. Influence team members regarding appropriate research methods Perform peer-review of work products from other statistical colleagues.
Communication of Results and Inferences
Collaborate with team members to write reports and communicate results. Assist with, or be responsible for, communicating study results via regulatory submissions, manuscripts, or oral presentations in group settings, as well as for communicating one-on-one with key customers and presenting at scientific meetings. Respond to regulatory queries and interact with regulators.
Therapeutic Area Knowledge
Understand disease states, competitive landscapes, and regulatory environment in order to enhance the level of customer focus and collaboration and be seen as a strong scientific contributor.
Regulatory Compliance
Perform work in full compliance with assigned curriculum(s) and will be responsible for following applicable Corporate, Medical, local, and departmental policies, procedures, processes, and training.
Statistical Leadership and Teamwork
Introduce and apply innovative methodology and tools to solve critical problems Merge scientific thinking and business knowledge to identify issues, evaluate options and implement solutions. Lead projects independently and work effectively across functions. Apply technical expertise to influence business decisions.
Qualifications
Required:
At least 7 years of proven experience in clinical research and development Preferred:
Significant experience with clinical trials, medical research, and/or real-world evidence Preferred:
Technical expertise and application with working knowledge of experimental design and statistical analysis Preferred:
An established track record of developing and maintaining an area of statistical or collaborative research Preferred:
Proficient in statistical programming languages/software such as SAS, R, Spotfire, WinBUG, etc Preferred:
Demonstrated problem solving ability and critical thinking Preferred:
Teamwork and leadership skills; ability to provide statistical leadership and technical expertise to influence business decisions Preferred:
Interpersonal communication skills for effective customer consultation and collaboration Preferred:
Creativity and innovation Preferred:
Business process expertise associated with critical activities (e.g. regulatory submissions) Education
Ph.D. in Statistics or Biostatistics
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